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ICH ICSR Implementation Guide 12 April 2013
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D.10.7.1.r.5 Comments
User Guidance This data element provides additional relevant information about the
‘medical condition’ in D.10.7.1.r that could not be captured otherwise in a
structured data element.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent
User Guidance This data element captures information about any other medical history
for the parent that could not be coded in D.10.7.1.r.
Conformance Optional
Data Type 10000AN
OID None
Value Allowed Free text
Business Rule(s)
D.10.8.r Relevant Past Drug History of Parent (repeat as necessary)
D.10.8.r.1 Name of Drug as Reported
User Guidance This data element captures the name of the medicinal product as reported
by the reporter. It is recognised that a single product can have different
proprietary names in different countries, even when it is produced by a
single manufacturer. See Section D.8.r.
Conformance Optional
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
D.10.8.r.2a MPID Version Date/Number
User Guidance See Section D.8.r.
Conformance Optional, but required if D.10.8.r.2b is populated.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-97-
D.10.7.1.r.5 Comments
User Guidance This data element provides additional relevant information about the
‘medical condition’ in D.10.7.1.r that could not be captured otherwise in a
structured data element.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent
User Guidance This data element captures information about any other medical history
for the parent that could not be coded in D.10.7.1.r.
Conformance Optional
Data Type 10000AN
OID None
Value Allowed Free text
Business Rule(s)
D.10.8.r Relevant Past Drug History of Parent (repeat as necessary)
D.10.8.r.1 Name of Drug as Reported
User Guidance This data element captures the name of the medicinal product as reported
by the reporter. It is recognised that a single product can have different
proprietary names in different countries, even when it is produced by a
single manufacturer. See Section D.8.r.
Conformance Optional
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
D.10.8.r.2a MPID Version Date/Number
User Guidance See Section D.8.r.
Conformance Optional, but required if D.10.8.r.2b is populated.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)